cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
💉
Other Drugs
💊 Drugs • 3,313 recalls
Class I - Dangerous
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
Bayer HealthCare Pharmaceuticals
Class I - Dangerous
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
Cambrex Charles City
Class I - Dangerous
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
Les Emballages Knowlton
Class I - Dangerous
Labeling: Label Mix Up- Incorrect back label applied to the product.
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
USCG Boat Response Kit - Product Code 80-0353, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Aid Backpack Kit - Product Code 85-0917, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.